FDA 510(k)

HeartFocus (V.1.1.1)

K-Number: K242807 · 2025-04-04

ApplicantDeski

Decision Date2025-04-04

Product CodeQJU

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HeartFocus (V.1.1.1) is the device name listed in this FDA 510(k) record. The listed applicant is Deski. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242807. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeartFocus (V.1.1.1)?

HeartFocus (V.1.1.1) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Deski. The 510(k) number is K242807.

When did HeartFocus (V.1.1.1) receive FDA 510(k) clearance?

HeartFocus (V.1.1.1) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242807.

Who is the listed applicant for HeartFocus (V.1.1.1)?

The FDA 510(k) record lists Deski as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeartFocus (V.1.1.1)?

The FDA product code for HeartFocus (V.1.1.1) is QJU.

Other records listing Deski as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260780HeartFocus

Related Devices (Code: QJU)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.